Song Lele, Chen Yan, Gong Yuan, Wan Jun, Guo Shaohua, Liu Hongyi, Li Yuemin, Zeng Zhen, Lu Yinying
Department of Radiotherapy, The Eighth Medical Center of the Chinese PLA General Hospital, No.17, Heishanhu Road, Beijing 100091, P.R. China.
Comprehensive Liver Cancer Department, The Fifth Medical Center of the Chinese PLA General Hospital, Beijing, P.R. China.
Ther Adv Med Oncol. 2020 Oct 16;12:1758835920962966. doi: 10.1177/1758835920962966. eCollection 2020.
The early detection of digestive cancers and precancerous diseases remains a significant challenge. This study aimed to investigate the performance of the blood methylated () assay, and the combination of this assay with serum protein markers, in hospital-based opportunistic screening strategies for digestive cancers.
Opportunistic screening was performed in the participating hospitals on outpatients and inpatients who met specific inclusion criteria. We recruited a total of 2030 subjects, including 764 cancer patients [291 colorectal cancer (CRC), 239 gastric cancer (GC), 106 esophageal cancer (EC), and 128 hepatocellular carcinoma (HCC)], 423 subjects with precancerous diseases, and 843 normal subjects. All samples were transported to an authenticated clinical laboratory where the tests were performed.
When used separately, the detected CRC, GC, EC, and HCC, with a sensitivity of 76.6% [area under the receiver operating characteristic curve (AUC) = 0.86)], 47.7% (AUC = 0.76), 42.6% (AUC = 0.69), and 76.7% (AUC = 0.85) and a specificity of 94.6%, 92.3%, 92.5%, and 87.7%, respectively. The assay also had potent ability to discriminate cancer from non-cancer subjects. The combination of with , , , or significantly enhanced the sensitivity for CRC, GC, EC, and HCC to 86.4% (AUC = 0.99, specificity = 92.8%), 63.6% (AUC = 0.86, specificity = 91.1%), 71.3% (AUC = 0.81, specificity = 82.1%), and 83.3% (AUC = 0.93, specificity = 85.1%), respectively. The performance of the assay was influenced by cancer stage, patient age, pathological types, and the location of cancer. We also identified that was an independent risk factor and was a valuable predictor for the long-term survival of digestive cancer patients, with a hazard ratio of 2.84, 2.07, 1.88, and 2.45, for CRC, GC, EC, and HCC, respectively.
The blood assay, whether used alone or in combination with serum protein markers, is effective for the opportunistic screening of digestive cancers. Furthermore, is an independent risk factor and a predictive marker for the long-term survival of digestive cancer patients.
消化道癌症及癌前疾病的早期检测仍然是一项重大挑战。本研究旨在探讨血液甲基化（）检测法以及该检测法与血清蛋白标志物联合使用在基于医院的消化道癌症机会性筛查策略中的表现。
在参与研究的医院中，对符合特定纳入标准的门诊患者和住院患者进行机会性筛查。我们共招募了2030名受试者，包括764名癌症患者[291例结直肠癌（CRC）、239例胃癌（GC）、106例食管癌（EC）和128例肝细胞癌（HCC）]、423例患有癌前疾病的受试者以及843名正常受试者。所有样本均被送往一家经过认证的临床实验室进行检测。
单独使用时，检测CRC、GC、EC和HCC的灵敏度分别为76.6%[受试者工作特征曲线下面积（AUC）=0.86]、47.7%（AUC=0.76）、42.6%（AUC=0.69）和76.7%（AUC=0.85），特异性分别为94.6%、92.3%、92.5%和87.7%。该检测法也具有强大的区分癌症患者与非癌症患者的能力。与、、或联合使用时，显著提高了CRC、GC、EC和HCC的灵敏度，分别达到86.4%（AUC=0.99，特异性=92.8%）、63.6%（AUC=0.86，特异性=91.1%）、71.3%（AUC=0.81，特异性=82.1%）和83.3%（AUC=0.93，特异性=85.1%）。检测法的表现受癌症分期、患者年龄、病理类型和癌症位置的影响。我们还确定是一个独立危险因素，并且是消化道癌症患者长期生存的有价值预测指标，对于CRC、GC、EC和HCC，其风险比分别为2.84、2.07、1.88和2.45。
血液检测法，无论是单独使用还是与血清蛋白标志物联合使用，对于消化道癌症的机会性筛查都是有效的。此外，是消化道癌症患者长期生存的独立危险因素和预测标志物。
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